1. Field of the Invention
The present invention is generally directed to an apparatus and method for facilitating a minimally invasive surgical procedure. More specifically, the subject apparatus and method is directed to facilitating manuary access to a sufflated body cavity during a hand-assisted laparascopic or other surgical procedure.
Minimally invasive surgical procedures such as laparascopic surgery have gained wide acceptance in various medical fields over traditional, fully invasive procedures for somewhat readily apparent reasons. Not only does the minimal invasiveness of such procedures significantly reduce the pain and stress to which a patient is otherwise subjected, they measurably reduce both the severity and duration of the recuperative period following surgery. The resulting benefits both in terms of cosmetic results and cost savings—are often quite considerable. Moreover, because they permit the required surgical manipulations to be carried out with the naturally enclosed biophysical environment at the surgery site kept substantially intact, such procedures minimize considerably the patient's exposure to potentially infectious or toxic organisms and contaminants. This, in turn, substantially minimizes the patient's risk of suffering medical complications.
In a typical laparoscopic surgical procedure, access to the surgery site—the abdominal or other internal body cavity, for instance—is gained through one or more fenestrations formed by puncturing the skin and the underlying muscle and soft tissue layers. A suitable miniature scope is introduced into the body cavity along with one or more laparoscopic instruments through shared or separate fenestrations. The surgeon may then perform the required surgical procedure by manipulating the laparoscopic instrument(s) and/or scope while acquiring visual feedback by viewing a video image of the site, as captured by the scope and reproduced on a display monitor.
As widely accepted and prevalent as they have become, however, such surgical procedures are not without their limitations. The surgeon's ability to adequately effect the precise cutting, suturing, and other very delicate surgical manipulations invariably required during laparoscopic procedures, for example, is highly dependent upon a set of critical factors including: the extensive experience and acute dexterity of the surgeon in performing the coordinated manipulations of the numerous laparoscopic instruments at hand; the degree of visibility attainable with the scope; and, the practical range of utility of the given instruments. A deficiency in any one of these factors severely obstructs the given procedure's successful completion and may, under certain circumstances, give rise to life threatening conditions. Hence, it not too infrequently becomes necessary to unexpectedly convert during the course of surgery to a fully invasive, open surgery.
Also, adhesions between the patient's internal organs at or around the surgery site tend to block or otherwise hinder the free manipulability of the laparoscopic instruments. It is difficult in such cases to maneuver an instrument between the adhering organs without potentially causing harm to either the organs or the instrument. Even where it is possible to adequately circumvent the adhering organs, much time and effort are unduly expended.
Of the more general limitations is the unavailability to the surgeon of any direct tactile sense of the surgery site. The instantaneous assessments that the surgeon must continually make as the surgical procedure progresses is consequently hindered by the lack of a key component of sensual feedback. The practicability of laparoscopic and like procedures is thus unduly restricted.
An approach developed to address these limitations is the so-called hand-assisted procedure, wherein the surgeon actually inserts a free hand into the given body cavity through a fenestration. With this free hand, the surgeon is able to supplement indirect, instrument-effected manipulations of organ and tissue parts with direct, hand-effected manipulations. Such direct hand manipulations often aid enormously in effecting difficult manipulations of organ and tissue that may otherwise be problematic using laparoscopic instrument maneuvers alone. With the free hand, the surgeon is also able to supplement the visual feedback acquired via the laparascopic scope with tactile sense feedback. Such supplemental feedback yields a vital source of additional information for either confirming or correcting visual assessments which, alone, may leave lingering ambiguity and general uncertainty.
While this manuary access to the surgery site greatly facilitates the conduct of minimally invasive surgical procedures, it too presents significant potential drawbacks and difficulties. First and most obvious, it necessarily compromises to some unavoidable extent the minimal invasiveness of the procedures. More notable than that, however, the sizable fenestration necessary to accommodate the manuary access threatens to compromise the body cavity's vital sufflation.
Consequently, there is a need for a method and apparatus by which a surgeon may safely and securely gain manuary access to an internal body cavity during a hand-assisted minimally invasive surgical procedure. There is a need for such method and apparatus that sufficiently establishes and maintains a substantially airtight seal across the fenestration which admits the surgeon's hand into the body cavity, yet does not unduly restrict or restrain the hand's movements. There is, furthermore, a need for such method and apparatus which is simple, convenient, and economical to utilize.
There is a further need for such method and apparatus by which the manuary access may be temporarily arrested, so that a surgeon may safely and conveniently remove his/her hand from the internal body cavity without substantial loss of seal across the fenestration or compromise of sterility. There is a need for this type of method and apparatus that permits the same surgeon or another surgeon/colleague to then re-insert their hand into the internal body cavity, re-establish manuary access without loss of seal or sterility, and resume the procedure.
2. Prior Art
Devices are known in the art for facilitating manuary access to an internal body cavity during hand-assisted laparoscopic surgical procedures. The inventor's own prior U.S. Pat. No. 6,471,714 is directed to such manuary access to sufflated body cavity. The disclosed approach provides highly effective manuary access when the disclosed apparatus is used continually during a procedure.
For instance, in U.S. Pat. No. 5,853,395 issued to Crook et al., an assembly is disclosed for providing extracorporeal pneumoperitoneum. The assembly includes a multi-part support ring structure which is adhesively affixed to the patient's abdominal surface surrounding the given fenestration; a collar-like wound protector which is inserted to line the exposed edges of the fenestration; and a flexible sleeve member about an open end of which a seal ring is attached. During use, the seal ring of the sleeve member is secured in sealed manner to the ring structure. The surgeon's hand, wearing a surgical glove, is passed to engage finger holes formed into an otherwise closed end of the sleeve member, then advanced first through the engaged seal ring and its supporting ring structure, and next through the wound protector, into the internal body cavity. The gas escaping through the fenestration is captured by the sleeve member, which is sealed and retained in place cooperatively by the seal ring and supporting ring structure.
While this assembly does enable manuary access to the internal body cavity, and even seeks to preserve pneumoperitoneum during that access, it nonetheless suffers from a number of very notable drawbacks which, in practice, diminish its utility. First, the assembly is quite substantial both in the number and complexity of its components. This not only further complicates matters for the surgeon already burdened by the numerous concerns relating to the surgical procedure at hand, it makes for a cumbersome structure that consumes an inordinate share of the precious area on the surface of the patient's abdomen—area necessary to adequately accommodate fenestrations for the passage of other instruments into the internal body cavity. Second, proper operation of the assembly hinges upon the support ring structure remaining adhesively affixed to the patient's abdominal skin surface throughout the surgical procedure which typically lasts hours on end. During the course of surgery, however, the cumulative effects of moisture, movements of the surgeon's hand, and other factors often erode the structure's adhesiveness to the point that it actually detaches from the patient's skin surface, thereby compromising the seal and openly exposing the surgery site to contaminants. What is more, adequate remedial measures are not readily available at that point, for it is extremely difficult to re-adhere the structure to the skin surface once adhesion is initially lost.
An additional drawback of note is the presence of openings in the form of finger holes formed at one end of the sleeve member. The material composition and makeup of the sleeve member is such that the holes not only require the surgeon's hand be covered by an inner surgical glove prior to passage of the fingers and thumb therethrough, and an outer surgical glove following passage of the fingers and thumb therethrough. The tightly fitting extraneous layers thus required about the surgeon's hand, in addition to being highly inconvenient to adorn, very undesirably constrict the surgeon's hand and constrain its movements—consequently heightening the discomfort experienced by the surgeon as well as the effort exerted by him or her. The extraneous layers also dull the covered hand's sensitivity, severely limiting the degree of useful sensual feedback that the surgeon might otherwise acquire by touch.
Another device known in the art is one disclosed in U.S. Pat. No. 5,480,410 issued to Cuschieri et al. for an extracorporeal pneumoperitoneum access bubble. The device forms a balloon-like spherical dome structure having a bottom opening whose neck is passed through a fenestration to serve as a conduit for insufflation gas migrating from the abdominal cavity. Thus maintained in an inflated state, the dome portion has formed therein a plurality of valves which permit access to various instruments without permitting significant leakage of the insufflation gas.
The device permits access also to a surgeon's hand, provided that the admitting valve formed in the dome portion is of sufficiently great size. The device, nonetheless, suffers from a number of the practical drawback s suffered by other similar devices known in the art. First and most obvious, the valve openings which permit access to instruments as well as the surgeon's hand necessarily interrupt the gas impermeable barrier extending over and about the fenestration. While they are designed to minimize it, the valve openings invariably permit leakage when accommodating an implement passed therethrough, especially since they are subjected to disturbing forces by the implements' manipulation during a given surgical procedure. This leakage would occur all the more where a valve opening is of extraordinary size—as it must be to accommodate the surgeon's hand and forearm; and where a valve opening is subjected to a substantial degree of disturbance—as would be caused by the surgeon's hand and forearm movements.
Another drawback is found in the considerable space necessarily occupied by the device's dome portion. The expansive volume permits few, if any, other instruments to share surrounding areas of the patient's abdominal skin surface. Indeed, the plurality of valve openings formed in the dome portion seemingly encourages common use of the device to admit multiple instruments into the abdominal cavity. Where additional instruments must be introduced into the abdominal cavity through neighboring fenestrations, in any event, the task becomes rather awkward, with the prevailing likelihood—even if neighboring instruments may be adequately introduced—of inadvertently making interfering contact with them.
Yet another drawback resides in the lack of adequate measures for maintaining the device sufficiently in place. As the insufflation gas migrates into and collects within its dome portion, the device is internally subjected to the intra-abdominal pressure that maintains insufflation of the abdominal cavity. With its resulting balloon-like structure, then, the device becomes somewhat unstable in its disposition, and tends in practice towards expulsion from its engagement with the fenestration.